in FDCA prosecutions
In reviewing any model jury instructions and charging documents, be aware
that the Ninth Circuit in 2002 held that "materiality" is an element of
a felony offense under 21 U.S.C. § 333(a)(2). United States v.
Watkins, 278 F.3d 961 (9th Cir. 2002). The opinion follows Neder v.
United States, 527 U.S. 1 (1999), and disagrees with United States v.
Jorgensen, 144 F.3d 550 (8th Cir. 1998), which interprets an analogous
statute as not imposing a "materiality" requirement. Watkins, like
Neder, relies on the common law meaning of "fraud" and "mislead."|
The same issue was before the Seventh Circuit in United States v.
Bhutani, 266 F.3d 661 (7th Cir. 2001), cert. den., 122 S. Ct. 2587
(2002). However, the Seventh Circuit did not address the issue, so
Watkins is the first post-Neder FDCA opinion on "materiality."
In Jorgensen, the Eighth Circuit rejected a materiality requirement for
the Federal Meat Inspection Act, which is a statute modeled on the FDCA.
Watkins, on the other hand, held that "materiality must be proven as an
element of the offense under either a theory of intent to defraud or a theory
of intent to mislead." Id. at 963.
This result dictates how "intent to defraud or mislead" must be approached
in districts in the Ninth Circuit. Moreover, care must be exercised in
dealing with "materiality" elsewhere. Because felony prosecutions generally
involve material falsehoods, the safer course is to include "materiality"
allegations in indictments and in jury instructions. (With respect to any
existing cases in which Watkins is used to challenge an indictment or
conviction, please consult with the Office of Consumer Litigation for briefs
and analysis of the "materiality" issue in the FDCA context. There are
arguments why "materiality" need not be a separate element under the FDCA.)
[cited in USAM 4-8.205]
[Added November 2002]